Cerebral PalsyNCT00726206
Correlation Between the Analysis of the Rapid Cortical Oscillations, the General Movements of the Preterm's and the Cerebral Palsy
A study testing Electroencephalogram, recording the movements in people with Cerebral Palsy, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
The general movement and the electroencephalogram analysis of the preterm have a high predictive value of the neuro-developmental outcome of the infants. Read more about this study
- Who is it for?
- Ages Up to 23 months
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Electroencephalogram, recording the movements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2008to Sep 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 23 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children been born between 15/01/08 and 15/01/10
- children whose term is lower than 28 weeks of amenorrhoea
Who cannot join
- Born child superior to 28 weeks of amenorrhoea
- presenting child a genic syndrome, an evolutionary neurological disease, a pathology malformative
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Médecine Infantile et Néonatologie, CHU Nord
Marseille, 13915
About this study
The general movement and the electroencephalogram analysis of the preterm have a high predictive value of the neuro-developmental outcome of the infants.
Read the detailed description
Compare the technical and the predictive characteristics of the qualitative analysis of the spontaneous motility with those of actual exams of reference diagnosis : magnetic resonance imaging, electroencephalogram and transfontanellar imaging.
- Conditions
- Cerebral Palsy
- Being tested
- Electroencephalogram, recording the movements
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroencephalogram, recording the movementsOther
Electroencephalogram, recording the movements of the child, RMI, Transfontanel Imaging
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Recording of the movements Recording of the electroencephalogram Receives: Other: Electroencephalogram, recording the movements |
What is being measured
The primary outcome is the main question the study is designed to answer.
To prove the predictive value of the " Deltas Brushes " triggered by hand or foot stimulation in correlation with the general movement analysis in the cerebral palsy diagnosis.
Measured: 36 months
Secondary outcomes (1)
To prove that the general movement of the preterm increases the predictive value the actual monitoring of the preterm's in the diagnosis of cerebral palsy.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionAug 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine GIRE, MD, Principal investigator, Assistance Publique des Hopitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00726206
- Sponsor's protocol ID
- 2008-A00062 53
- Other IDs
- 2008-02
- Status last verified
- Aug 2014
- First submitted
- 30 Jul 2008
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Zahed-Cheikh M, Brevaut-Malaty V, Busuttil M, Monnier AS, Roussel M, Gire C. Comparative analysis of perinatal and postnatal factors, and general movement in extremely preterm infants. Brain Dev. 2011 Sep;33(8):656-65. doi: 10.1016/j.braindev.2010.10.023. Epub 2011 Jan 26.
PubMed 21273017
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between the Analysis of the Rapid Cortical Oscillations, the General Movements of the Preterm's and the Cerebral Palsy
- ClinicalTrials.gov ID
- NCT00726206
- Acronym / sponsor ID
- 2008-A00062 53
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 31 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The general movement and the electroencephalogram analysis of the preterm have a high predictive value of the neuro-developmental outcome of the infants.
Detailed description
Compare the technical and the predictive characteristics of the qualitative analysis of the spontaneous motility with those of actual exams of reference diagnosis : magnetic resonance imaging, electroencephalogram and transfontanellar imaging.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: Electroencephalogram, recording the movementsRecording of the movements Recording of the electroencephalogram |
Who may qualify
- Ages
- Up to 23 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children been born between 15/01/08 and 15/01/10
- children whose term is lower than 28 weeks of amenorrhoea
Key exclusion criteria (2 listed)
- Born child superior to 28 weeks of amenorrhoea
- presenting child a genic syndrome, an evolutionary neurological disease, a pathology malformative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electroencephalogram, recording the movementsElectroencephalogram, recording the movements of the child, RMI, Transfontanel Imaging | Other | 1 |
Primary outcome
To prove the predictive value of the " Deltas Brushes " triggered by hand or foot stimulation in correlation with the general movement analysis in the cerebral palsy diagnosis.
Time frame: 36 months
1 secondary outcome
To prove that the general movement of the preterm increases the predictive value the actual monitoring of the preterm's in the diagnosis of cerebral palsy.
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Results publication: PubMed 21273017Zahed-Cheikh M, Brevaut-Malaty V, Busuttil M, Monnier AS, Roussel M, Gire C. Comparative analysis of perinatal and postnatal factors, and general movement in extremely preterm infants. Brain Dev. 2011 Sep;33(8):656-65. doi: 10.1016/j.braindev.2010.10.023. Epub 2011 Jan 26.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine GIRE, MD principal investigator
Assistance Publique des Hopitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroencephalogram, recording the movements in people with Cerebral Palsy, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To prove the predictive value of the " Deltas Brushes " triggered by hand or foot stimulation in correlation with the general movement analysis in the cerebral palsy diagnosis. (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00726206, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.